At TPP Negotiations, U.S. Trade Rep Attempts to Resolve Pharmaceuticals Impasse by Wrapping Same Harmful Proposal in Different Packaging

Despite the Spin, Five Plus Three Still Equals Eight

ATLANTA – At the Trans-Pacific Partnership (TPP) negotiations in Atlanta, the U.S. Trade Representative (USTR) is pushing the same harmful pharmaceutical proposal that many countries have rejected as recently as August – but wrapped in different packaging.

The tactic is designed to break negotiators’ impasse over biotech drugs. The TPP talks in Maui collapsed a month ago when trade ministers sparred over several issues including biologics exclusivity. But the U.S. proposal would give pharmaceutical companies additional monopoly protections at the expense of public budgets and people’s health, Public Citizen said today.

The USTR has long pushed for increased marketing exclusivity periods for biologics – medical products derived from living organisms, including many new and forthcoming cancer treatments. Exclusivity means product monopolies, with no competition from generics or biosimilars; medicine prices in the tens and hundreds of thousands of dollars per person; and the rationing of treatment access. Marketing exclusivity is separate from and independent of patent protection, though the protections may overlap. The USTR has supported an eight-year minimum monopoly period, while a majority bloc of negotiating countries will not consider more than five years’ exclusivity.

The approach reportedly being explored by some negotiators would require a minimum five years marketing exclusivity followed by a three-year minimum period of post-marketing surveillance, which would also exclude competition through an unusual mechanism found in Japanese law. The approach would allow some countries to claim they are not changing their exclusivity laws or prior trade agreement deals on intellectual property and access to medicines, per public commitments those governments have made. But it would also allow the USTR to report to the pharmaceutical industry that they have secured eight-year biotech monopolies.

In other words, 5+3 = 8.

“This is a cynical rebranding of a failed negotiating position,” said Peter Maybarduk, director of Public Citizen’s Global Access to Medicines program. “It represents the worst of secretive trade deals – a rule that has nothing to do with trade, but will lead to preventable suffering. You can put a suit and tie on this, but it still stinks. Non-U.S. TPP negotiators and trade ministers should continue standing strong against this USTR demand, because, despite the spin, five plus three still equals eight.”